Pharyngeal wall treatment

ABSTRACT

A patient&#39;s pharyngeal wall is treated by inserting an expander member into the airway and positioning an active portion of the expander member in opposition to portions of the pharyngeal wall to be treated. The expander member is activated to urge the wall portions outwardly to an outwardly displaced position. The expander member is then deactivated while leaving the wall portions in the outwardly placed position and the expander member is removed from said airway. A further aspect of the treatment includes stabilization of at least a portion of the pharyngeal wall after compression of portions of the wall.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.11/451,988, filed Jun 13, 2006; which is a continuation of U.S.application Ser. No. 10/066,967, filed Feb. 4, 2002, now U.S. Pat. No.7,146,981 issued Dec. 12, 2006; which applications are incorporatedherein by reference.

BACKGROUND

1. Field of the Invention

This invention is directed to methods and apparatuses for treating thepharyngeal wall of a patient. More particularly, this invention pertainsto method and apparatus for treating a pharyngeal wall area as part of asleep apnea treatment.

2. Description of the Prior Art

Sleep apnea and snoring are complex phenomena. Commonly assigned U.S.Pat. No. 6,250,307 describes various prior techniques and discloses anovel treatment for such conditions (including a permanent palatalimplant).

These prior art teachings include Huang, et al., “Biomechanics ofSnoring”, Endeavour, p. 96-100, Vol. 19, No. 3 (1995). That publicationestimates that up to 20% of the adult population snores habitually.Snoring can be a serious cause of marital discord. In addition, snoringcan present a serious health risk to the snorer. In 10% of habitualsnorers, collapse of the airway during sleep can lead to obstructivesleep apnea syndrome. Id. In addition to describing a model for palatalflutter, that publication also describes a model for collapse of thepharyngeal wall.

Notwithstanding efforts have been made to treat snoring and sleep apnea.These include palatal treatments such as electrical stimulation of thesoft palate. See, e.g., Schwartz, et al., “Effects of electricalstimulation to the soft palate on snoring and obstructive sleep apnea”,J. Prosthetic Dentistry, pp. 273-281 (1996). Devices to apply suchstimulation are described in U.S. Pat. Nos. 5,284,161 and 5,792,067.Such devices are appliances requiring patient adherence to a regimen ofuse as well as subjecting the patient to discomfort during sleep.Electrical stimulation to treat sleep apnea is discussed in Wiltfang, etal., “First results on daytime submandibular electrostimulation ofsuprahyoidal muscles to prevent night-time hypopharyngeal collapse inobstructive sleep apnea syndrome”, International Journal of Oral &Maxillofacial Surgery, pp. 21-25 (1999).

Surgical treatments for the soft palate have also been employed. Onesuch treatment is uvulopalatopharyngoplasty (UPPP) where about 2 cm ofthe trailing edge of the soft palate is removed to reduce the softpalate's ability to flutter between the tongue and the pharyngeal wallof the throat. See, Huang, et al., supra at 99 and Harries, et al., “TheSurgical treatment of snoring”, Journal of Laryngology and Otology, pp.1105-1106 (1996) which describes removal of up to 1.5 cm of the softpalate. Assessment of snoring treatment is discussed in Cole, et al.,“Snoring: A review and a Reassessment”, Journal of Otolaryngology, pp.303-306 (1995). Huang, et al., propose an alternative to UPPP whichproposal includes using a surgical laser to create scar tissue on thesurface of the soft palate. The scar is to reduce flexibility of thesoft palate to reduce palatal flutter. RF ablation (so-calledSomnoplasty as advocated by Somnus Technologies) is also suggested totreat the soft palate. RF ablation has also been suggested for ablationof the tongue base.

In pharyngeal snoring and sleep apnea, the pharyngeal airway collapsesin an area between the soft palate and the larynx. One technique fortreating airway collapse is continuous positive airway pressure (CPAP).In CPAP air is passed under pressure to maintain a patent airway.However, such equipment is bulky, expensive and generally restricted topatients with obstructive sleep apnea severe enough to threaten generalhealth. Huang, et al. at p. 97.

Treatments of the pharyngeal wall include electrical stimulation issuggested in U.S. Pat. No. 6,240,316 to Richmond et al. issued May 29,2001, U.S. Pat. No. 4,830,008 to Meer issued May 16, 1989, U.S. Pat. No.5,158,080 to Kallok issued Oct. 27, 1992, U.S. Pat. No. 5,591,216 toTesterman et al. issued Jan. 7, 1997 and PCT International PublicationNo. WO 01/23039 published Apr. 5, 2001 (on PCT International ApplicationNo. PCT/US00/26616 filed Sep. 28, 2000 with priority to U.S. Ser. No.09/409,018 filed Sep. 29, 1999). U.S. Pat. No. 5,979,456 to Magoverndated Nov. 9, 1999 teaches an apparatus for modifying the shape of apharynx. These teachings include a shape-memory structure having anactivated shape and a quiescent shape. Dreher et al., “Influence ofnasal obstruction on sleep-associated breathing disorders”, So.Laryngo-Rhino-Otologie, pp. 313-317 (June 1999), suggests using nasalstents to treat sleep associated breathing disorders involving nasalobstruction. Upper airway dilating drug treatment is suggested inAboubakr, et al., “Long-term facilitation in obstructive sleep apneapatients during NREM sleep”, J. Applied Physiology, pp. 2751-2757(December 2001).

Surgical treatments for sleep apnea are described in Sher et al., “TheEfficacy of Surgical Modifications of the Upper Airway in Adults withObstructive Sleep Apnea Syndrome”, Sleep, Vol. 19, No. 2, pp. 156-177(1996). Anatomical evaluation of patients with sleep apnea or othersleep disordered breathing are described in Schwab, et al., “UpperAirway and Soft Tissue Anatomy in Normal Subjects and Patients withSleep-Disordered Breathing”, Am. J. Respir. Crit. Care Med., Vol. 152,pp. 1673-1689 (1995) (“Schwab I”) and Schwab et al., “Dynamic UpperAirway Imaging During Awake Respiration in Normal Subjects and Patientswith Sleep Disordered Breathing”, Am. Rev. Respir. Dis., Vol. 148, pp.1385-1400 (1993) (“Schwab II). In Schwab I, it is noted that apneicpatients have a smaller airway size and width and a thicker lateralpharyngeal wall. For reviews of pharyngeal wall thickness and otherstructure and obstructive sleep apnea, see, also, Wheatley, et al.,“Mechanical Properties of the Upper Airway”, Current Opinion inPulmonary Medicine, pp. 363-369 (November 1998); Schwartz et al.,“Pharyngeal airway obstruction in obstructive sleep apnea:pathophysiology and clinical implication”, Otolaryngologic Clinics of N.Amer., pp. 911-918 (December 1998); Collard, et al., “Why should weenlarge the pharynx in obstructive sleep apnea?”, Sleep, (9 Suppl.) pp.S85-S87 (November 1996); Winter, et al., “Enlargement of the lateralpharyngeal fat pad space in pigs increases upper airway resistance”, J.Applied Physiology, pp. 726-731 (September 1995); and Stauffer, et al.,“Pharyngeal Size and Resistance in Obstructive Sleep Apnea”, Amer.Review of Respiratory Disease, pp. 623-627 (September 1987)

SUMMARY OF THE INVENTION

According to one aspect of the present invention, methods andapparatuses are disclosed for treating a pharyngeal airway having apharyngeal wall of a patient at least partially surrounding and definingsaid airway. The method includes inserting an expander member into theairway and positioning an active portion of the expander member inopposition to portions of the wall to be treated. The expander member isactivated to urge the wall portions outwardly to an outwardly displacedposition. The expander member is then deactivated while leaving the wallportions in the outwardly placed position and the expander member isremoved from said airway. A further aspect of the invention includesstabilization of at least a portion of the pharyngeal wall in theoutwardly placed position after compression of portions of the wall.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows, in cross-section, a naso-pharyngeal area of an untreatedpatient;

FIG. 2 is the view of FIG. 1 with the soft palate containing an implantin the form of a bolus of micro-beads deposited in a linear path;

FIG. 3 is a frontal view of the patient of FIG. 3 showing an alternativeembodiment with micro-beads deposited as spherical deposits;

FIG. 4 is a schematic representation showing a patch for delivering abolus of micro-beads through a plurality of needles;

FIG. 5 is a schematic cross-sectional view (taken generally along line5-5 in FIG. 2) of a pharyngeal airway at a position in a person with theairway defined by opposing portions of a pharyngeal wall and a base of atongue;

FIG. 6 is the view of FIG. 5 with a first embodiment of an expandermember in position prior to activation;

FIG. 7 is the view of FIG. 6 following activation of the expander memberto compress portions of the pharyngeal wall;

FIG. 8 is a side-sectional view of compression pads used in the expandermember of FIG. 7;

FIG. 9 is the view of FIG. 7 following deactivation and removal of theexpander member and showing retention of the pharyngeal wall in anexpanded state;

FIG. 10 is the view of FIG. 6 showing an alternative embodiment of theinvention;

FIG. 11 is the view of FIG. 6 showing a further alternative embodimentof the invention;

FIG. 12 is the view of FIG. 6 showing a still further alternativeembodiment of the invention;

FIG. 13 is a schematic cross-sectional view (taken generally along line13-13 in FIG. 2) of a pharyngeal airway at a position in a person distalto the base of the tongue and with the airway defined by the pharyngealwall;

FIG. 14 is the view of FIG. 13 with a further embodiment of an expandermember positioned in the airway in a deactivated state;

FIG. 15 is the view of FIG. 14 with the expander member shown activatedcompressing the pharyngeal wall;

FIG. 16 is the view of FIG. 15 following deactivation and removal of theexpander member and showing retention of the pharyngeal wall in anexpanded state;

FIG. 17 is a sectional schematic view of a compressed portion of tissuedefining, in part, a pharyngeal airway and stabilized by a biocompatiblematerial in the tissue of the compressed portion;

FIG. 18 is the view of FIG. 17 with the compressed tissue stabilized bysuture material;

FIG. 19 is the view of FIG. 17 but with the tissue not being compressedand being stabilized by a suture material;

FIG. 20 is a side-sectional schematic view of a suture material havingresorbable and non-resorbable portions;

FIG. 21 is the view of FIG. 18 with the suture material of FIG. 20 priorto resorption of the resorbable portions of the suture material; and

FIG. 22 is the view of FIG. 21 with the suture material of FIG. 20following resorption of the resorbable portions of the suture material.

DESCRIPTION OF THE PREFERRED EMBODIMENT A. Physiology Background

Referring now to the several drawing figures, in which identicalelements are numbered identically throughout, a description of apreferred embodiment of the present invention will now be provided.

The disclosures of U.S. Pat. No. 6,250,307 and PCT InternationalPublication No. WO 01/19301 (PCT/US00/40830) are incorporated herein byreference.

FIG. 1 shows, in cross-section, a naso-pharyngeal area of an untreatedpatient. FIG. 1 shows the nose N, mouth M and throat TH. The tongue T isshown in an oral cavity OC of the mouth. A hard palate HP (containing abone B) separates the oral cavity OC from the nasal cavity NC. The nasalconcha C (soft tissue which defines, in part, the nasal sinus—not shown)resides in the nasal cavity NC.

The soft palate SP (a muscle activated soft tissue not supported bybone) depends in cantilevered manner at a leading end LE from the hardpalate HP and terminates at a trailing end TE. Below the soft palate SP,the pharyngeal wall PW defines the throat passage TP. A nasal passage NPconnects the nasal cavity NC to the pharyngeal wall PW. Below anepiglottis EP, the throat passage TP divides into a trachea TR forpassing air to the lungs and an esophagus ES for passing food and drinkto the stomach.

The soft palate SP is operated by muscles (not separately shown andlabeled) to lift the soft palate SP to urge the trailing edge TE againstthe rear area of the pharyngeal wall PW. This seals the nasal cavity NCfrom the oral cavity OC during swallowing. The epiglottis EP closes thetrachea TR during swallowing and drinking and opens for breathing.

For purposes of this disclosure, the nasal cavity NC, oral cavity OC andthroat passage TP are collectively referred to as the naso-pharyngealarea of the patient (defining, in part, the pharyngeal airway PA inFIGS. 5 and 13) with the area including the various body surfaces whichcooperate to define the nasal cavity NC, oral cavity OC and throatpassage TP. These body surfaces include outer surfaces of the nasalconcha C, the upper and lower surfaces of the soft palate SP and outersurfaces of the pharyngeal wall PW. Outer surfaces means surfacesexposed to air. Both the upper and lower surfaces of the soft palate SPare outer surfaces.

Snoring can result from vibration of any one of a number of surfaces orstructures of the naso-pharyngeal area. Most commonly, snoring isattributable to vibration of the soft palate SP. However, vibratoryaction of the nasal concha C and the pharyngeal wall PW can alsocontribute to snoring sounds. It is not uncommon for vibratory actionfrom more than one region of the naso-pharyngeal area to contribute tosnoring sounds. Sleep apnea can result from partial or full collapse ofthe naso-pharyngeal wall during sleep.

FIG. 5 shows a schematic representation of a cross-section of a throatwith the pharyngeal airway PA defined by the pharyngeal wall PW and thetongue T. The anterior-posterior axis is labeled AP to assist indiscerning the orientation. The pharyngeal wall PW is shown as includingthe left lateral pharyngeal wall LLPW, right lateral pharyngeal wallRLPW and posterior pharyngeal wall PPW.

B. Disclosure of Prior Application

In addition to disclosing the teachings of U.S. Pat. No. 6,250,307 andthe teachings of selected embodiments of PCT International PublicationNo. WO 01/19301 (both incorporated herein by reference), commonlyassigned and co-pending patent application U.S. Ser. No. 09/636,803,filed Aug. 10, 2000, which is hereby incorporated by reference in itsentirety, describes techniques for stiffening tissue of the pharyngealairway with a bolus of particulate matter. FIGS. 2 and 3 show are takenfrom the '803 application and show an implant 10 as a bolus ofparticulate matter. An example of such particulate matter would bemicro-beads. An example of such is taught in U.S. Pat. Nos. 5,792,478and 5,421,406. These patents teach carbon-coated metallic or ceramicparticles having cross-sectional dimensions of between 100 and 1,000microns. The particles are carried in a fluid or gel. These patentsstate that upon insertion into body tissue, the particles do not migratesignificantly and, apparently due to fibrotic response, the tissue intowhich the particles are injected stiffens.

The particles of U.S. Pat. Nos. 5,792,478 and 5,421,406 are one exampleof particles for stiffening injection. Such particles can also includeceramic particles or pure carbon or other bio-compatible particles. Theparticles can be carried in a liquid or gel medium. The particles canhave multi-modal particle size distributions (i.e., a mix of two or moresizes of particles with the smaller particles filling interstitialspaces between larger particles).

The bolus 10 of particles can be applied by a needle to inject the bolus10 into the soft palate SP. The bolus can be the same volume as thevolume of the implants 20 of FIGS. 8 and 9 of U.S. Pat. No. 6,250,307.With reference to FIG. 3, a multiple of bolus injections can be made inthe soft palate resulting in deposition of generally spherical deposits10′ of particles. Alternatively, an injecting needle can be withdrawnwhile simultaneously ejecting particles for the bolus 10 (FIG. 2) to bedeposited in a line similar in dimensions to the implants 20 of FIGS. 8and 9 of U.S. Pat. No. 6,250,307.

The foregoing emphasizes the use of implants to stiffen the soft palateSP. Implants 10 can be placed in any of the tissue of thenaso-pharyngeal area (e.g., the concha C, soft palate SP or pharyngealwall PW) to treat snoring. Also, such a treatment can stiffen the tissueof the throat and treat sleep apnea resulting from airway collapse bystiffening the airway.

While a needle deposition of a bolus of particles may be preferred, thebolus can be applied in other manners. FIG. 4 (which is a reproductionof FIG. 16 of the '803 application) illustrates deposition ofparticulates through a patch 12 having a volume 14 containing suchmicro-beads 16.

One side 12 a of the patch 12 contains an array of micro-needles 18communicating with the volume 14. The needles 18 may be small diameter,shallow penetration needles to minimize pain and blood. Examples ofshallow, small diameter needles are shown in U.S. Pat. No. 5,582,184 toErickson et al. Placing the surface 12 a against the tissue (e.g., thepharyngeal wall PW as shown in FIG. 4), the needles 18 penetrate theouter surface of the tissue PW. The patch 12 can then be compressed (byfinger pressure, roller or the like) to eject the beads 16 from thevolume 14 through the plurality of needles 18. The patch 12 can beprovided with interior dividing walls (not shown) so that some of thevolume of beads 16 is ejected through each needle 18. The side 12 a actsas a stop surface to ensure control over the penetration depth of theneedles 18 to reduce risk of undesired puncture of underlyingstructures.

Stiffening of the naso-pharyngeal tissue provides structure to reducevibration and snoring. Such structure reduces airway collapse as atreatment for sleep apnea.

C. Pharyngeal Wall Compression

FIGS. 5-16 show various methods and apparatus for enlarging thepharyngeal airway PA. As will be described, further disclosure is madefor stiffening the tissue or maintaining the enlarged airway size.

FIG. 6 is the view of FIG. 5 showing an expander member 20 positionedwithin the pharyngeal airway PA for the purpose of treating thepharyngeal wall PW. As will become apparent, the treatment includesenlargement of the pharyngeal airway PA by urging at least portions ofthe pharyngeal wall PW outwardly. In the embodiment of FIG. 6, the rightand left lateral pharyngeal wall portions RLPW, LLPW are being urgedoutwardly to increase the area of the airway PA.

The expander member 20 includes left and right supports 22 positionedopposing the right and left lateral pharyngeal wall portions RLPW, LLPW.Compression pads 24 are carried on the supports 22 and in directopposition to the right and left lateral pharyngeal wall portions RLPW,LLPW. The supports 22 are maintained in fixed spaced apart relation by aspacer bar 26.

While not shown in the drawings, the spacer bar 26 can be adjustable topermit a physician to modify the spacing between the supports 22 and topermit narrowing the spacing between the supports 22 to facilitate easeof placement of the expander member 20 in the airway PA at a desiredtreatment area. Preferably, the pads 24 and supports 22 have a length(distance parallel to the longitudinal axis of the airway PA) greaterthan a width (distance parallel to the opposing surface of the wall PWas indicated by W in FIG. 6) to treat an extended length of the wall PW.For example, the pads 24 and supports 22 could be about two centimeterslong.

The compression pads 24 are inflatable bladders connected by a tube 28(FIG. 8) to a source of a pressurized fluid (not shown). Admission ofpressurized fluid into the bladders 24 causes the bladders to enlargeurging the right and left lateral pharyngeal wall portions RLPW, LLPWoutwardly as illustrated in FIG. 7. The compression of the tissue of thepatient could be compression of the pharyngeal wall PW or compression oftissue surrounding the pharyngeal wall PW (for example, fatty pads).After the compression, the pads 24 are deflated and the expander member20 is removed from the airway PA as illustrated in FIG. 9 leavingcompressed right and left lateral pharyngeal wall portions RLPW, LLPWand an enlarged cross-sectional area of the pharyngeal airway PA.

In addition to compressing the walls of the pharyngeal airway PA, thecompressed walls may be stabilized in a compressed state to ensurelonger lasting retention of the therapeutic benefits of the enlargedairway PA. This stabilization can include injecting a bio-adhesive orbio-sealants into the tissue adjacent the treated portions of thepharyngeal wall.

An example of bio-adhesives includes cyanoacrylates. Without intendingto be a limiting example, these include 2-octyl cyanoacrylate and2-butyl cyanoacrylate. The 2-octyl cyanoacrylate is developed by ClosureMedical Corp., Raleigh, N.C., USA for use to treat topical skin wounds,oral cancers and periodontal disease. It may last 1-2 weeks with fasterabsorbing products in development. The 2-butyl cyanoacrylate is used asa skin protectant and dental cement and is available from GluStitch,Inc., Delta, BC, Canada

Biocompatible adhesives also include surgical adhesives such as thosedeveloped by CryoLife International, Inc., Kennesaw, Ga., USA whoseproduct is composed of purified bovine serum albumin (45%) andcross-linking agent glutaraldehyde (10%). Similar formulations includenatural proteins (e.g., collagen, gelatin) with aldehyde or othercross-link agents.

Such bio-sealants may be fibrin sealants. Examples include blood-derivedproducts (e.g., Tisseel™ distributed by Baxter Corp., Deerfield, Ill.,USA). Other examples of coatings include hydrogel coatings. An exampleof these include a photo-curing synthetic sealant developed by Focal,Inc., Lexington, Mass., USA which can adhere to moist or dry tissue andis highly flexible and elastic. This sealant may be absorbable overshort or long terms. The sealant is currently used to treat air leaksassociated with lung surgery. Other coatings include denture adhesivesapproved for use in humans.

From the foregoing, it can be seen there are a wide variety of adhesivesand other coatings suitable for use with the present invention. Theforegoing lists are intended to be illustrative and not exhaustive.

With the description given with respect to FIGS. 6-9, the bio-stabilizercan be injected into the compressed regions of tissue adjacent the rightand left pharyngeal wall. For example, the material can be injected intothe compressed portions of the right and left lateral pharyngeal wallportions RLPW, LLPW (mucosal or sub-mucosal or muscular tissue) or intocompressed tissue behind the right and left pharyngeal walls, such ascompressed fatty tissues. The expander 20 can be left in place while theadhesive as least partially sets such that when the expander 20 isremoved, the adhesive helps retain the compressed right and left lateralpharyngeal wall portions RLPW, LLPW in a compressed state.

Bio-adhesives degrade and the therapeutic benefit of the bio-adhesivescan be lost over time. Accordingly, a still further embodiment of thepresent invention includes injecting a fibrosis-inducing agent into thecompressed tissue. The fibrosis-inducing agent induces a fibroticresponse of the tissue to stiffen the tissue and helping to retain thetissue in a compressed state.

It will be appreciated that the fibrosis-inducing agent may be used inconjunction with the bio-adhesive or the bio-adhesive andfibrosis-inducing agents can be used separately. In the preferredembodiment the fibrosis-inducing agent will be substantiallynon-biodegradable so as to provide a long lasting, chronic effectmaintaining the compressed state of the pharyngeal wall PW.

By way of non-limiting example, a fibrosis-inducing material may bemicrobeads as described above. While microbeads may be a preferredembodiment, alternative techniques for inducing fibrosis can be in theform of placement in the compressed tissue of polyester material orother foreign bodies which induce a fibrotic response.

In addition to the adhesives or fibrosis-inducing agents, drugs may beadmitted into the tissue. Drugs may be injected directly or inmicrospheres.

FIG. 8 illustrates an embodiment for injecting adhesives or microbeadsinto the compressed tissue by the use and placement of micro needles 30on a side of the bladder 24 opposing the tissue similar to theembodiment of FIG. 4. The fluid from the bladder 24 through the needles30 contains the bio-adhesives and the microbeads. The micro needles 30can be of various lengths to vary the depth of distribution of theadhesives and the microbeads.

FIGS. 10-12 show alternative embodiments of the present invention.Elements having functions in common with the fore-going embodiment arenumbered identically with the addition of a suffix (“a”, “b” or “c”) todistinguish the embodiments.

In FIGS. 6 and 7, compression members 24 are shown only opposing theright and left lateral pharyngeal wall portions RLPW, LLPW. In FIG. 12,four compression members 24 a are shown to cover a wider area of theright and left lateral pharyngeal wall portions RLPW, LLPW. In FIG. 11,three compression members 24 b are shown for compressing not only theright and left lateral pharyngeal wall portions RLPW, LLPW but also theposterior pharyngeal wall PPW. In FIG. 10, an arcuate and continuouscompression member 24 c is shown for compressing the entire pharyngealwall PW.

FIGS. 13-15 illustrate use of the method of the present invention in adifferent region of the pharyngeal airway PA. With respect to FIGS.6-12, the embodiments of the invention are shown in use in that portionof the pharyngeal airway PA which is defined in part by the base of thetongue T. Further distal into the pharyngeal airway PA, the pharyngealairway PA is defined by the pharyngeal wall PW as illustrated in FIG.13. The present invention is also applicable to treatment of thenaso-pharynx NP (FIG. 1) in which case the airway is defined by lateraland posterior pharyngeal walls and opposing surfaces of the palate.Since this is similar to the shown applications, separate illustrationsneed not be provided.

FIG. 14 shows a circular airway expander member 20′ having a circularsupport 22′ and a circular bladder 24′. Since the support 22′ isannular-shaped, an unobstructed airway PA remains to permit respirationby the patient during treatment. FIG. 15 shows the device with thebladder 22′ in an expanded state to cause compression of the pharyngealwall PW. FIG. 16 shows the compressed pharyngeal wall following removalof the expander member 20′.

FIGS. 17-22 illustrate various examples of techniques for stabilizingthe pharyngeal wall PW. FIG. 17 illustrates a region of compressedtissue CT impregnated with a stabilizing material 40 (e.g., adhesive,sealant or microbeads).

The compressed tissue CT may be compressed mucosal tissue or may becompressed muscular tissue. Also, the compressed tissue CT may becompressed fatty pads adjacent the pharyngeal wall PW.

Stabilization could result from a chemical agent (e.g., a sclerosingagent) or by application of energy (e.g., radiofrequency ablation) orany other means (e.g., cryogenic ablation). It will be appreciated thatnot all of these techniques need provide a permanent stabilization andsome of these techniques may result in remodeling over time. Subsequenttreatments may then be provided.

FIG. 18 illustrates a mechanical stabilization using suture material 42to hold the compressed tissue in a compressed state. The suture materialmay be resorbable or non-resorbable. FIG. 19 is similar to FIG. 18 butthe pharyngeal wall is not compressed. Instead, the pharyngeal wall isstabilized by sutures 44 to underlying structure US (e.g., to underlyingbucco-pharyngeal fascia, prevertebral fascia, anterior longitudinalligament or vertebral bodies). Attachment to such bodies may also occurfollowing compression. Stabilization can result from tacking to anysub-mucosal area surrounding the pharyngeal airway.

FIGS. 20-22 illustrate a variation of FIG. 18 where the suture material46 includes a short non-resorbable core 48 (e.g., poly estertetrapthalate—PET) covered by a longer outer coating 50 of resorbablesuture material. Immediately after the implantation, only the resorbableends extend out of the pharyngeal wall PW into the airway PA and aretied off (see FIG. 21). Following resorption, the non-resorbable portion48 is fully recessed behind the wall PW as shown in FIG. 22 to limitpossibility of later migration of the non-resorbable core 48 into theairway PA. In the foregoing, the term “suture” is not intended to belimited to a thread-like material but can include clips or any otherclosure mechanism.

The foregoing describes numerous embodiments of a method and apparatusto treat a pharyngeal wall. Having described the invention, alternativesand embodiments may occur to one of skill in the art. For example, aphysician may stabilize all or a portion of the pharyngeal wall withinthe teachings of the foregoing with conventional surgical instruments.It is intended that such modifications and equivalents shall be includedwithin the scope of the following claims.

1. An apparatus for treating sleep apnea by treating a pharyngeal airwayhaving a pharyngeal wall of a patient at least partially surrounding anddefining said airway, said method comprising; an expander memberdimensioned so as to be inserted into said airway with an active portionof said expander member positioned in an interior of said airway andexternal to a tissue of said pharyngeal wall and in opposition to anairway-defining tissue of portions of said wall to be treated; anactivator for activating said expander member to urge against saidairway-defining tissue of said portions to urge said portions outwardlyto an outwardly displaced position; an applicator to treat said portionsin said outwardly displaced position with a treatment to retain saidportions in said outwardly displaced position following deactivation ofsaid expander member for a time sufficient to treat obstructive sleepapnea; said expander member adapted to be deactivated while leaving saidportions in said outwardly displaced position; said expander memberfurther dimensioned so as to be removable from said airway.
 2. Anapparatus according to claim 1 wherein said expander member includes afluid inflatable member and said activator includes a connection betweensaid fluid inflatable member and a source of fluid under pressure.
 3. Anapparatus according to claim 1 wherein said expander member includes aninjector for injecting a biocompatible adhesive into compressed tissueadjacent said portions while said portions are in said outwardlydisplaced positions.
 4. An apparatus according to claim 1 furthercomprising an injector for injecting a fibrosis-inducing agent intocompressed tissue adjacent said portions while said portions are in saidoutwardly displaced positions.